Clearance Summary
CO2 Laser Therapy System (K106) received FDA 510(k) clearance under submission number K252519, sponsored by Hebei Keylaser Sci-Tech Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-11-07.
- Submission: K252519
- Applicant / Sponsor: Hebei Keylaser Sci-Tech Co.,Ltd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2025-11-07
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.